The outsourced IRB: A successful case study
'People were concerned about the liability'
Research institutions continually look for ways to make their operations more efficient, especially during lean economic times. But one option that sometimes is overlooked because of tradition is the possibility of outsourcing the IRB functions.
Columbia St. Mary's Hospital in Milwaukee, WI, first began to consider this option close to five years ago after an external audit recommended the research institution centralize its research operations into one clinical trial office, says Diana Lenhardt, manager of clinical trials operations.
"I pulled together a research task force, including members of our local IRB, hospital executives, nursing staff, and research staff, to look at the pros and cons of keeping or outsourcing the local IRB," Lenhardt says.
"That's where we started the process, and we wound up recommending that we outsource the IRB," she adds.
Investigators and clinical research staff have been very satisfied with the change, Lenhardt says.
"It's extremely efficient, and the IRB review turnaround time is fabulous," she says.
Lenhardt was hired five years ago to manage clinical trials operations in the newly-formed clinical trials office. Her role was to serve as gatekeeper of all research and to communicate with every department involved in clinical trials. She also did IRB coordinating, which proved challenging.
"I could have spent half of my time just doing IRB work," she recalls.
Yet, the bulk of her work involved managing the entire research operations, leaving too little energy and time for the IRB.
It had become clear that the organization would need to hire a dedicated IRB manager or outsource. Here are the steps the hospital took to reach the conclusion that it would be more efficient to outsource IRB work:
Task force reviews IRB structure: The research task force closely examined the IRB structure, asking these questions:
Do we want to keep our local IRB?
If we do keep our local IRB, what could we do to make it more efficient and effective?
"We decided we'd definitely have to ramp up our education for IRB members, meet more regularly, and hire a dedicated person to do the IRB work," Lenhardt says. "You also need IRB members who will take the time and commit to the work."
By comparison, task force members looked at what an external IRB could offer.
"When we looked at outsourcing the IRB, we looked at the expertise they have, frequency of meetings, and turnaround time," Lenhardt says. "We looked at the pros and cons for the IRB and how if we outsourced the IRB then that would free me up to pay attention to the legal, compliance, financial, billing, and all the other pieces that constitute the operational role."
The task force also determined that Lenhardt's role if the IRB was outsourced would be to serve as a liaison between the research organization and the external IRB.
Discuss drawbacks, concerns: "When we first looked at the IRB being potentially outsourced, the committee members were opposed to it because they didn't want to lose control of the research," Lenhardt says.
Other concerns involved having to pay the IRB fee and handling HIPAA waivers.
"We have a lot of medical students and residents who we teach and who have to do research, and there was concern about these students not being able to pay for those IRB fees," she says. "Also, people were concerned about the liability of outsourcing IRB work."
The task force met twice a month for six months, continuing to review the pros and cons.
"The recommendation finally was to outsource the IRB only if we have a research oversight committee locally that would act as a privacy board for anyone who wants a HIPAA waiver," Lenhardt says.
Going before hospital leadership: "We carried the message that we wanted to outsource the IRB through the chain of command," she says.
As discussions continued, some people thought the research oversight committee should have some IRB duties, but the task force disagreed: "If we have an IRB then we have an IRB, or else it's gone totally," Lenhardt says.
Everyone finally decided the new research oversight committee would be the policy-making body for the human subjects protection program and the arbiter of disputes on ethics issues. These are in addition to its duties as a privacy board.
"They have not diverted from that mission and do not try to be an IRB," Lenhardt says.
Finding the right IRB: "When we decided to use a central IRB, we requested proposals, solicited IRBs, and used a scoring tool when we interviewed IRBs," she says.
"We pared down our decision to our top three, and the task force selected our IRB of choice," she adds. "Then we put together a recommendation for how we wanted to disband our local IRB and begin using the IRB of choice."
The recommendation included details on how the research oversight committee would be formed, including its purpose and function.
"When we got approval to move forward with the central IRB, we put agreements in place, and our local IRB remained for another year," Lenhardt says.
Transitioning studies: During the transition period, Lenhardt notified all investigators and clinical research staff of the change and how it would affect their studies.
Their main question was about who would pay for the new IRB's review fees.
"When we transitioned those old studies to the new IRB, I asked our foundation for financial support for all of the transition fees to the new IRB, and the foundation agreed to pay," Lenhardt notes. "We had principal investigator-initiated studies and cooperative group studies, and the foundation provided all of the funding for that transition, and that was a key piece."
After the transition period, the research office maintained a research account from which the IRB fees are paid. Industry study sponsors reimburse the account for the cost of the IRB fees.
She transitioned all studies to the new IRB at a pace of about two studies per week.
"We had about 70 studies that I had to transition for continuing review," Lenhardt says. "I sorted all studies by the date in which they would expire."
The new IRB reviewed studies at their continuing review, which completed the transition for those particular trials.
Also, any new studies that arrived were immediately sent to the new IRB for review.
After all ongoing and new studies were fully moved to the new IRB, the hospital disbanded the local IRB.
"I'm the gatekeeper for any research," Lenhardt says. "The system works extremely well: anything that comes through goes to me first, and then I send it to the IRB.
Research institutions continually look for ways to make their operations more efficient, especially during lean economic times.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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